FRUQUINTINIB - Generic Drug Details

What are the generic sources for fruquintinib and what is the scope of freedom to operate?

Fruquintinib is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fruquintinib has seventy-six patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for FRUQUINTINIB

International Patents:	76
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	148
Patent Applications:	563
What excipients (inactive ingredients) are in FRUQUINTINIB?	FRUQUINTINIB excipients list
DailyMed Link:	FRUQUINTINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FRUQUINTINIB

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FRUQUINTINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federation Francophone de Cancerologie Digestive	NA
National Cancer Institute (NCI)	PHASE2
Fudan University	PHASE3

See all FRUQUINTINIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FRUQUINTINIB

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for FRUQUINTINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	8,212,033
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No	11,046,674
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	7,829,574		Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No	7,829,574		Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	11,046,674

International Patents for FRUQUINTINIB

Country	Patent Number	Title	Estimated Expiration
Philippines	12017500451	CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL) OXY)-N, 2-DIMETHYLBENZOFURAN -3- CARBOXAMIDE
Spain	2819242
Philippines	12017500451	CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL) OXY)-N, 2-DIMETHYLBENZOFURAN -3- CARBOXAMIDE
Serbia	60829	KRISTALNI OBLICI 6-((6, 7-DIMETOKSIHINAZOLIN-4-IL)OKSI)-N,2-DIMETILBENZOFURAN-3-KARBOKSAMIDA (CRYSTALLINE FORMS OF 6-((6, 7-DIMETHOXYQUINAZOLIN-4-YL)OXY) -N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE)
Eurasian Patent Organization	201790275
Malaysia	176618	CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL)OXY)- N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE

Supplementary Protection Certificates for FRUQUINTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3191475	C20240047	Finland
3191475	CA 2024 00052	Denmark		PRODUCT NAME: FRUQUINTINIB; REG. NO/DATE: EU/1/24/1827 20240625
3191475	2024C/553	Belgium		PRODUCT NAME: FRUQUINTINIB; AUTHORISATION NUMBER AND DATE: EU/1/24/1827 20240625
3191475	24C1055	France		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 20240625
3191475	LUC00372	Luxembourg		PRODUCT NAME: CRYSTALLINE FORMS OF 6-((6, 7-DIMETHOXYQUINAZOLIN-4-YL)OXY) - N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1827 20240625
3191475	122024000069	Germany		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 20240620

Market Dynamics and Financial Trajectory for Fruquintinib

Last updated: March 5, 2026

What is Fruquintinib and its approved indications?

Fruquintinib is an oral, small-molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3. It is developed by Chinese pharmaceutical company Hutchison China MediTech (Chi-Med). The drug primarily targets angiogenesis in tumor growth.

Approved indications include metastatic colorectal cancer (mCRC) after failure of standard therapies in China. It remains unapproved in the U.S. and Europe. The regulatory agency in China, the National Medical Products Administration (NMPA), approved Fruquintinib in 2018.

How is the market segmented?

Geographic segmentation:

• China: primary market, with regulatory approval and commercialization.
• Rest of Asia: limited penetration, contingent on approvals.
• Global: No approval outside China; market growth depends on regulatory acceptance.

Cancer type:

• Colorectal cancer: main focus.
• Other indications: potential expansion, including gastric and other solid tumors.

Competitive landscape:

• Bevacizumab (Avastin): global VEGFR inhibitor.
• Lenvatinib (Lenvima): multi-targeted kinase inhibitor.
• Regorafenib (Stivarga): similar oral multi-kinase inhibitor, approved for colorectal cancer.

Fruquintinib positions as a cost-effective alternative within China for colorectal cancer patients after standard therapies.

What are current sales figures and revenue trends?

2022 financials:

Item	Amount	Notes
Total sales revenue	~$130 million	Primarily from China sales
Market share in Chinese mCRC	~30%	Among VEGFR inhibitors

Growth trajectory:

• 2018: Launch with initial revenues in China less than $10 million.
• 2020: Sales surged to approximately $60 million following approval and increased adoption.
• 2022: Growth plateaued, with revenues stabilizing at ~$130 million.

Key drivers:

• Expanded line of therapies.
• Increasing number of eligible patients.
• Government reimbursement schemes improving access.

What are the factors influencing future revenue growth?

Regulatory landscape:

• No approvals outside China limit expansion potential.
• International regulatory pathways (e.g., FDA approval) would unlock global markets.

Market penetration:

• High unmet need in China for second-line colorectal cancer treatments.
• Potential for market share gains with increased awareness and use.

Competition:

• Regorafenib has a significant presence but is more costly and associated with different side effect profiles.
• Lenvatinib and bevacizumab are in broader indications but are more expensive.

Pricing and reimbursement policies:

• China's government health insurance negotiations influence price points.
• A lower price point compared to global competitors positions Fruquintinib as a value-focused option.

Pipeline and expansion potential:

• Clinical trials exploring use in gastric, lung, and other cancers.
• Potential label expansion broadens revenue streams.

Risks:

• Dependence on Chinese regulatory and reimbursement landscape.
• Competitive entry from global VEGFR inhibitors.
• Possible side effect management issues affecting adherence.

How do financial expectations compare with similar drugs?

Drug	Approved Indications	Peak Sales (2022)	Market Share	Development Stage
Fruquintinib	mCRC (China)	~$130 million	30% (Chinese VEGFR market)	Established in China
Regorafenib	mCRC, GIST, HCC	~$350 million	Global presence	Mature, global approval
Lenvatinib	Thyroid, renal, endometrial	~$2 billion	Large, diversified	Global approval
Bevacizumab	Multiple solid tumors	~$8 billion	Broadest access	Global approval

Key challenges and opportunities

Challenges

• Limited geographical reach.
• Competition from global VEGFR inhibitors.
• Regulatory hurdles for international expansion.
• Price sensitivity in China impacting margins.

Opportunities

• Expansion into other Asian markets.
• Clinical trials for new indications.
• Strategic partnerships for global licensing.
• Increasing adoption due to cost advantages.

Conclusions on financial trajectory

Fruquintinib is positioned for steady growth within the Chinese market driven by unmet clinical needs, government reimbursement, and competitive pricing. Its growth potential hinges on regulatory approval outside China, pipeline development, and competitive dynamics. Revenues are expected to stabilize or modestly grow, barring major expansion successes or new approvals.

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Key Takeaways

• Fruquintinib is a VEGFR inhibitor approved exclusively in China for metastatic colorectal cancer.
• Revenue of approximately $130 million in 2022 reflects strong market penetration in China.
• Growth prospects depend on regulatory approvals outside China and pipeline expansion.
• Competition from global VEGFR inhibitors may impact market share.
• Cost advantages and unmet need position Fruquintinib as a key player in China’s oncology space.

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FAQs

1. What are the main drivers of Fruquintinib sales in China?
Clinical unmet needs, government reimbursement, and competitive pricing are primary drivers.

2. Will Fruquintinib expand into other indications?
Potential exists, with ongoing trials exploring gastric, lung, and other solid tumors.

3. Are there plans for international approval?
No public plans, but international regulatory pathways remain a future possibility.

4. How does Fruquintinib compare price-wise to competitors?
It is generally priced lower, making it a cost-effective alternative in China.

5. What are key risks for future growth?
Limited global presence, competitive pressures, and regulatory hurdles.